MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-16 for TRI-EX 8.5MM G22530 manufactured by Cook Medical.
[31206866]
Patient Sequence No: 1, Text Type: N, H10
[31206867]
According to the department's report, "the extraction balloon is supposed to blow up a whole 360 degrees. It would not blown up correctly. " instead of blowing up like a sphere, it blew up into a kidney shape. There was no patient impact, no complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5224968 |
| MDR Report Key | 5224968 |
| Date Received | 2015-11-16 |
| Date of Report | 2015-10-22 |
| Date of Event | 2015-09-05 |
| Report Date | 2015-10-22 |
| Date Reported to FDA | 2015-10-22 |
| Date Reported to Mfgr | 2015-10-22 |
| Date Added to Maude | 2015-11-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRI-EX |
| Generic Name | SINGLE USE 3-LUMEN BALLOON CATHETER AND BALLOON |
| Product Code | FTJ |
| Date Received | 2015-11-16 |
| Model Number | 8.5MM |
| Catalog Number | G22530 |
| Lot Number | W3603285 |
| ID Number | TX-8.5A |
| Device Expiration Date | 2016-07-01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK MEDICAL |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-16 |